Lenses, IntraocularNCT05392738
Visual Function and Patient Satisfaction in Glaucoma or Ocular Hypertensive Patients Undergoing Simultaneous Cataract Surgery and i-Stent Implantation
An observational study of Lenses, Intraocular and Glaucoma Filtration Implants, run by Clínica Rementería at 1 site in Spain.
Trial summary
New extended depth of focus intraocular lenses (IOLs) are being used in a broader spectrum of patients than trifocal IOLs. The purpose of this study is to evaluate visual improvement after cataract surgery in patients with glaucoma or ocular hypertension undergoing simultaneous cataract surgery with i-Stent… Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Lenses, Intraocular, Glaucoma Filtration Implants
- What is being tested?
- I-Stent implantation
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jun 2022to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with glaucoma or ocular hypertension or healthy subjects undergoing bilateral cataract surgery with Vivity intraocular lens implantation with or without i-Stent implantation
Inclusion Criteria: Bilateral cataract surgery with Vivity implantation with or without i_STent implantation
Exclusion Criteria: Ocular disease other than glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
New extended depth of focus intraocular lenses (IOLs) are being used in a broader spectrum of patients than trifocal IOLs. The purpose of this study is to evaluate visual improvement after cataract surgery in patients with glaucoma or ocular hypertension undergoing simultaneous cataract surgery with i-Stent implantation with the implantation of a Vivity IOL. Results will be compared with a group of glaucoma or ocular hypertension undergoing isolated cataract surgery with Vivity implantation, as well as with patients with no pathology undergoing cataract surgery and Vivity implantation
Read the detailed description
The purpose of this study is to report in detail visual function and patient satisfaction, as well as the need for spectacle correction, in patients with glaucoma and ocular hypertension undergoing cataract surgery with bilateral implantation of an extended depth of focus IOL, the Vivity IOL. The study also seeks to determine if there are differences in the speed of visual improvement between patients undergoing isolated cataract surgery and patients undergoing simultaneous i-Stent implantation. Results will also be compared with a group of patients with no ocular pathology undergoing cataract surgery with Vivity implantation.
Patients will be asked to join the study once the type of surgery (isolated phacoemulsification versus phacoemulsification combined with i-Stent implantation) and the type of lens to be implanted (monofocal, EDoF, trifocal) has been agreed between ophthalmologist and patient. Therefore, inclusion in the study will have no influence on surgical indication.
Once informed consent has been signed, the patient will be included in the study.
Explorations specific for the study will be performed 3 and 12 months after surgery and include:
Defocus curves Contrast sensitivity Self-reported photic phenomena Need for spectacle correction Satisfaction measured with the Catquest SF9 questionnaire
Besides study-specific procedures, the following explorations which are standard of care will be performed one day, one week and one month after surgery:
Uncorrected binocular visual acuity for distance, intermediate and near distances Monocular distance corrected and uncorrected visual acuity Residual subjective refraction Slit-lamp examination Intraocular pressure and number of hypotensive drugs required Description of any intra- or postsurgical complications
- Conditions
- Lenses, Intraocular, Glaucoma Filtration Implants
- Being tested
- I-Stent implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-Stent implantationDevice
I-Stent implantation
| Study group | Role | What they receive |
|---|---|---|
| Vivity with i-Stent | Patients with Glaucoma or Ocular Hypertension undergoing simultaneous cataract and i-Stent implantation, with Vivity intraocular lens Receives: Device: I-Stent implantation | |
| Glaucoma with Vivity | Patients with Glaucoma or Ocular Hypertension undergoing isolated phacoemulsification with Vivity intraocular lens | |
| Healthy with Vivity | Patients with undergoing isolated phacoemulsification with Vivity intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular uncorrected distance visual acuity
Binocular uncorrected distance visual acuity
Measured: Three months after surgery
Binocular uncorrected intermediate visual acuity
Binocular uncorrected intermediate visual acuity
Measured: Three months after surgery
Binocular uncorrected near visual acuity
Binocular uncorrected near visual acuity
Measured: Three months after surgery
Secondary outcomes (6)
Binocular uncorrected distance visual acuity
Binocular uncorrected distance visual acuity
Measured: One month after surgery
Binocular uncorrected intermediate visual acuity
Binocular uncorrected intermediate visual acuity
Measured: One month after surgery
Binocular uncorrected near visual acuity
Binocular uncorrected near visual acuity
Measured: One month after surgery
Contrast sensitivity
Contrast sensitivity
Measured: Three months after surgery
Need for spectacle correction
Need for spectacle correction
Measured: Three months after surgery
Patient satisfaction
Patient satisfaction evaluated with the Catquest SF9 questionnaire
Measured: Three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start20 Jun 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lenses, IntraocularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clínica Rementería
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatriz Puerto, MD, Principal investigator, Clínica Rementería
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392738
- Sponsor's protocol ID
- 22/265-O_P
- Status last verified
- Jul 2022
- First submitted
- 23 May 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Function and Patient Satisfaction in Glaucoma or Ocular Hypertensive Patients Undergoing Simultaneous Cataract Surgery and i-Stent Implantation
- ClinicalTrials.gov ID
- NCT05392738
- Acronym / sponsor ID
- 22/265-O_P
- Conditions
- Lenses, Intraocular, Glaucoma Filtration Implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Clínica RementeríaUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
New extended depth of focus intraocular lenses (IOLs) are being used in a broader spectrum of patients than trifocal IOLs. The purpose of this study is to evaluate visual improvement after cataract surgery in patients with glaucoma or ocular hypertension undergoing simultaneous cataract surgery with i-Stent implantation with the implantation of a Vivity IOL. Results will be compared with a group of glaucoma or ocular hypertension undergoing isolated cataract surgery with Vivity implantation, as well as with patients with no pathology undergoing cataract surgery and Vivity implantation
Detailed description
The purpose of this study is to report in detail visual function and patient satisfaction, as well as the need for spectacle correction, in patients with glaucoma and ocular hypertension undergoing cataract surgery with bilateral implantation of an extended depth of focus IOL, the Vivity IOL. The study also seeks to determine if there are differences in the speed of visual improvement between patients undergoing isolated cataract surgery and patients undergoing simultaneous i-Stent implantation. Results will also be compared with a group of patients with no ocular pathology undergoing cataract surgery with Vivity implantation.
Patients will be asked to join the study once the type of surgery (isolated phacoemulsification versus phacoemulsification combined with i-Stent implantation) and the type of lens to be implanted (monofocal, EDoF, trifocal) has been agreed between ophthalmologist and patient. Therefore, inclusion in the study will have no influence on surgical indication.
Once informed consent has been signed, the patient will be included in the study.
Explorations specific for the study will be performed 3 and 12 months after surgery and include:
Defocus curves Contrast sensitivity Self-reported photic phenomena Need for spectacle correction Satisfaction measured with the Catquest SF9 questionnaire
Besides study-specific procedures, the following explorations which are standard of care will be performed one day, one week and one month after surgery:
Uncorrected binocular visual acuity for distance, intermediate and near distances Monocular distance corrected and uncorrected visual acuity Residual subjective refraction Slit-lamp examination Intraocular pressure and number of hypotensive drugs required Description of any intra- or postsurgical complications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vivity with i-Stent | – | Device: I-Stent implantationPatients with Glaucoma or Ocular Hypertension undergoing simultaneous cataract and i-Stent implantation, with Vivity intraocular lens |
| Glaucoma with Vivity | – | –Patients with Glaucoma or Ocular Hypertension undergoing isolated phacoemulsification with Vivity intraocular lens |
| Healthy with Vivity | – | –Patients with undergoing isolated phacoemulsification with Vivity intraocular lens |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with glaucoma or ocular hypertension or healthy subjects undergoing bilateral cataract surgery with Vivity intraocular lens implantation with or without i-Stent implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-Stent implantationI-Stent implantation | Device | Vivity with i-Stent |
Primary outcome
Binocular uncorrected distance visual acuity
Time frame: Three months after surgery
Binocular uncorrected distance visual acuity
Binocular uncorrected intermediate visual acuity
Time frame: Three months after surgery
Binocular uncorrected intermediate visual acuity
Binocular uncorrected near visual acuity
Time frame: Three months after surgery
Binocular uncorrected near visual acuity
6 secondary outcomes
Binocular uncorrected distance visual acuity
Time frame: One month after surgery
Binocular uncorrected intermediate visual acuity
Time frame: One month after surgery
Binocular uncorrected near visual acuity
Time frame: One month after surgery
Contrast sensitivity
Time frame: Three months after surgery
Need for spectacle correction
Time frame: Three months after surgery
Patient satisfaction
Time frame: Three months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz Puerto, MD principal investigator
Clínica Rementería
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lenses, Intraocular and Glaucoma Filtration Implants, run by Clínica Rementería at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular uncorrected distance visual acuity (time frame: Three months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.